The aktaPD® team is proficient in the strategic plan, design, analysis, and reporting of clinical trial data across all therapeutic indications and phases of drug development. Our proven process of preparing the statistical analysis plan (SAP), validating derived datasets, and producing and reviewing tables will keep your development plan on target and within budget.
Does your project demand biostatistical excellence? Contact us.
Our experts work closely with you to prepare a detailed pharmaceutical product development plan – from target product profile to Phase 0/first-in-human trials (FIH) to an NDA or BLA filing – that covers all technical aspects (clinical, nonclinical, regulatory, and CMC) and includes detailed cost estimates and time lines.
Ready to improve your clinical studies and optimize time, money, and results. Contact us.
Our seasoned scientists deliver clinical pharmacology studies, IND through Phase 4, including bioanalytical, in vitro and in vivo ADME, and preclinical/clinical pharmacokinetics. We’re accomplished at translating basic practical research (Translational Medicine) into a targeted and reasoned development of therapeutics by applying our unique approach to model-based drug development that begins in discovery.
Ready for an action-oriented approach to pharmaceutical development? Contact us.
Our experts bring a wealth of experience in managing large budgets and overseeing commercial analytics, market access, medical affairs, and life-cycle strategies and tactics on a global scale, leading to the formulation of evidence plans and development strategies for early stage assets. With deep expertise in the commercial assessment of in-licensing opportunities for medicines and medical technologies, our world-class team is adroit in due diligence and business development activities as well as in mobilizing, supporting, and leading strategic partnerships.
Ready for strong leadership from proven experts in the commercialization? Contact us.
CRA – Clinical Research Associate
aktaPD®’s senior CRAs work closely with sites to identify potential risks associated with set-up, enrollment, quality, and management of all clinical activities. Our team’s goal is clear: better, collaborative decision-making on site selection and subject/investigator engagement efforts resulting in optimal trial execution that is cost- and time-effective, compliant, and with a solid contingency plan to manage and mitigate risk.
Need support in writing and managing global study protocols that work? Contact us.
Our team of veteran pharmaceutical drug developers oversees and governs the multiple facets of a CRO, double-checking processes to ensure timely and accurate delivery on your goals, from preclinical to post-marketing phases. Our experts review budgets for accurate and fair pricing, assess comprehensive time lines, make sure key milestones and deliverables across groups are met, and liaise with departments and stakeholders, within and outside your company. aktaPD® experts help your CRO identify and resolve challenges, manage budgets, produce regular executive summaries, and present to shareholders and regulatory authorities.
Need an experienced, dedicated team who has your back and can support your CRO for success? Contact us.
We know that “business as usual” in today’s competitive, high-stakes pharma world doesn’t fly with FDA, EMA, and payers, and can seriously affect your time line–and bottom line–costing you more in every way. aktaPD® helps you get it right the first time, working with you to assess your unique needs and develop a strategic course of action that ensures corporate success, providing guidance as you hurdle operational barriers, and ultimately saving money. Our experts draw on decades of experience in all aspects of pharmaceutical operations to support your efforts to enhance revenue, efficiency, quality, and cost-reduction…from discovery to market.
Ready to talk Opportunity? Contact us.
Database Management / EDC
Our data management team’s approach to collecting and processing study data makes certain that high quality deliverables occur on time, within budget through the use of intuitive technologies, good planning, superb training, and excellent monitoring and controls. We manage database lock as a seamless, cyclical, ongoing built-in process, from study set-up to the closing phase of the lock.
Want a trusted resource for data management/EDC? Contact us.
Small, privately funded, and not quite ready to hire up, but still in need of an interim CMO, clinical development team, or medical monitors? That’s what we do: We are your stopgap experts who help keep your pipeline in production mode while you build the right team. Our consortium of seasoned C-suite executives uses strategic coaching and development to turn your existing team into a dream team. R&D, commercial operations, supply chain, and more, we can leverage your investment in the people you have on-board right now and extend your reach with the addition of seasoned interim staff.
Want a second set of eyes in your organization for a fresh perspective and a reenergized approach? Contact us.
Safeguarding your organization and reputation while minimizing financial risk is our HCP Compliance team’s job. We help you assess risk and monitor your aggregate spend (Physician Payments Sunshine Act) with healthcare professionals and organizations in the form of honoraria, gifts, travel, and more. We keep you up-to-date and in integrity with the growing body of rules, and rigorously manage the adherence of your vendors to not only your team’s diverse needs but also to stated regulations. Our experienced experts help you spend as wisely and effectively as possible, to get the most out of your HCPs.
Ready to experience the Iron Wolf in action? Contact us.
Our knowledge transfer/e-learning solutions are innovative and cost-effective, making training stimulating and efficient, whether it’s site and investigator training for clinical trials, disease state education for employees and sites, or training on company rules and regulations. Assessments and user metrics ensure accountability. Whether the medium is mobile, web-based, social, traditional, or a combination, we can structure the learning experience to meet the needs of all your learners and save you and your stakeholders time and money.
Want to see how collaboration can take you to the next level of knowledge transfer innovation? Contact us.
KOL and Site Engagement
We’re deeply familiar with the investigator community and know that excellent relationships facilitate excellent studies. We start faster, smarter, and better because people, processes, and expectations are already known. This has an enormous impact on site contract negotiations, finalizations, and collection of regulatory documents. We are uniquely positioned to assist in identifying potential centers that have met enrollment goals in the past and are renowned for providing high quality data. We enjoy good rapport and valuable relationships because we provide excellent support to investigative site personnel—from eligibility to SAE management.
Good rapport, great sites, the best industry KOLs: Are you ready to make these your differentiating values? Contact us.
Through the perfect balance of creativity, content, and technical expertise, and backed by years of experience in smoothly managing legal and regulatory review sessions, aktaPD® helps you strategically grow your business with professional, high quality, creative solutions that work – for you and your stakeholders. We are experts at maximizing your company’s profile, its message, and its impact across all platforms, uniquely tailored to your product, audiences, and needs, including technical documents and publications, public relations, video production, website development, email marketing, social media, advertising, and meetings and events.
Interested in taking the next step and differentiating your product for optimal effect and lasting impact? Contact us.
We specialize in identifying all aspects of Capacity Planning, including human, procedural, equipment, and total facility utilization. Our Capacity Planning strategies can be effectively performed at individual sites as well as global networks, and empower your management to make informed decisions about how and when to increase capacities while minimizing overhead costs.
Are you ready for a team who is truly connected to your deliverables, from time line to the end of the line? Contact us.
Our sophisticated quality management check-and-balance system includes strict monitoring using a safety database to chart data entry inconsistencies and ensure compliance. Then we enhance with oversight by our expert medical monitors, moving the process beyond check-and-balance straight to bull’s-eye! Our globally-positioned monitors provide 24/7/365 on-call telephone availability; eCRFs; medical reviews of AE, concomitant medication, and safety events; training; site guidance; study support; and document development and review.
Interested in a bull’s-eye approach that perfectly unites QC, safety, and clinical trial success? Contact us.
Our medical writers use their comprehensive industry experience to create objective, clear, crisp, data-driven documents and reports that meet both sponsor and regulatory expectations. Their expertise includes INDs, protocols, CSRs, transcripts of advisory board meetings, peer review materials, abstracts, press releases, grants, investor brochures, shareholder communications, executive summaries, scientific articles and publications, internal SOPs, protocols, and vendor contracts.
Do you need a partner who can deliver clear, accurate study and regulatory documents? Contact us.
Our team is expert at swiftly and wisely moving from bench to bedside, harnessing the power of translational medicine, along with modeling and simulation, to forward drug development and speed the right, safe medicines to patients at the right time. Our integrated approach to research boosts your ROI by getting to endpoints faster and smarter, via toxicologic pathology, efficacy studies, results/risk analysis and interpretation, reports and papers, and regulatory expertise.
Need support in the scientific discovery process by an expert team, passionate about research? Contact us.
aktaPD®’s global safety and pharmacovigilance team includes knowledgeable trained clinicians and nurses expert in providing comprehensive pharmacovigilance service and post-marketing safety surveillance. Our team provides call center services, pre-approval SAE management, post-marketing AE/SAE management, product complaint/defect reports, post-marketing medical information, global ICSR and aggregate report regulatory authority submissions, literature review, aggregate report development and reporting, and, of course, direct patient care.
Want an expert partner committed to patient safety and study success? Contact us.
Preclinical / Nonclinical Development
aktaPD® can support your preclinical and nonclinical development processes with the effective communication and superb execution of a diverse and skilled team that includes toxicologists, basic scientists, clinical development physicians, pharmacologists, statisticians, and regulatory affairs professionals. Our deeply experienced global experts are capable of understanding the intended clinical plan for a drug candidate and anticipating potential roadblocks so they can execute the most effective preclinical strategy. We provide a framework for defining the desired features of the new drug, known or suspected risks and liabilities, team organization, in-clinic safety monitoring programs, and metrics of success. Our goal? To help you determine your product’s ultimate safety profile.
Need a world-class team to support you along the path of preclinical development? Contact us.
Our program management team ensures success by creating a detailed, fully-realized project blueprint of all operations and procedures, including creating and managing time lines, budgets, a communications plan citing responsibilities, status reports, reviews, and action steps for the resolution of issues for key stakeholders on all teams–ours, yours, and vendors.
Interested in how aktaPD® can be an effective partner in global clinical trials development and execution? Contact us.
Quality Controls / Assurance, & Auditing
We develop, manage, and validate quality systems including Part 11 compliance, foreign CMO oversight and batch record review, GLP studies, GXP training and documents, GCP site audits, EDC/RDC data verification, supplier qualification, SOPs, GMP training, and FDA/European global requirements. Expert at quality and audits, our team delivers outstanding due diligence for clinical trial sites, laboratories, suppliers, distributors, CROs, and manufacturers in the US, Europe, and Canada.
Interested in a smart approach to QC that complies with the latest regulatory and quality standards? Contact us.
Regulatory Operations / Strategy
Along with regulatory approval activities of strategy, pre- and INDs, navigating the FDA review process, and filing, our capabilities include marketing approval submission activities: developing and maintaining detailed time lines, determining how best to pool and present data from the completed clinical trials, and coordinating the efforts of personnel from multiple functional areas (clinical, nonclinical, CMC, statistics). And if an assessment of in-licensing M&A opportunities or internal development options is required, we provide invaluable assistance by critically reviewing nonclinical, clinical, medical, regulatory, and/or commercial documentation to assure that it is scientifically sound, acceptable, and reimbursable.
Ready for a seasoned team to advocate for you and help turn your good ideas into marketable products? Contact us.
aktaPD® assists physicians and pharma professionals in harnessing the power of technology to safely and quickly inform their patients and staffs. Our expert team has access to various technology platforms to analyze data, qualify metrics, customize tracking, test hypotheses, quantify results, and deliver reports. We unite the latest technology with our advanced knowledge transfer capabilities to help you effectively share information with all your constituents, both internal and external. Most importantly, we ensure that all data are secure and HIPAA-compliant.
Is your organization ready for a partner who does not take a traditional approach to drug development, who believes in actions, not words? Contact us.
Ready for an action-oriented approach to pharmaceutical development?
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